The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.

Study Overview

• Status: Recruiting
• Conditions: Non Muscle Invasive Bladder Cancer
• Intervention / Treatment: Procedure: Urine biomarker -Guided without reTURBT

Detailed Description

This clinical trial aims to address the clinical question of whether a urine biomarker test can effectively guide the decision-making process regarding the necessity of reTURBT (repeat transurethral resection of bladder tumor) in patients with non-muscle-invasive bladder cancer (NMIBC). The primary objective is to assess whether patients with negative urine biomarker tests can safely avoid reTURBT. Participants eligible for enrollment in this study will be randomized in a 1:2 ratio into two groups:Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT. Following reTURBT, they will also receive standard follow-up care. The main task for participants will involve providing urine samples for the biomarker test before reTURBT. Those in Group B will additionally undergo reTURBT, a standard surgical procedure involving the removal of residual tumor tissue from the bladder.Throughout the study period, researchers will assess their recurrence-free survival rates and RFS. The goal is to determine whether the urine biomarker test can safely spare patients from unnecessary reTURBT while maintaining comparable RFS rates. This study adheres to ethical guidelines and has obtained approval from the appropriate institutional review boards. Participant confidentiality and data integrity will be strictly maintained throughout the study duration. The results of this trial have the potential to inform clinical practice guidelines and improve the management of NMIBC patients by offering a personalized approach to treatment decision-making.

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Lv, Ph.D; Email: doctorlvqiang@sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • the First Affiliated Hospital of Nanjing Medical University
      • Contact: Qiang Lv, Ph.D; Email: doctorlvqiang@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians;
• Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT;
• Age ≥ 18 years;
• Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results;
• Willingness to sign informed consent.

Exclusion Criteria:

• Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
• Patients previously diagnosed with muscle-invasive bladder cancer;
• Patients unable to undergo a second transurethral resection;
• Patients with incomplete sample pathology information;
• Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements;
• Patients unable to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urine biomarker -Guided without reTURBT; Participants in this arm will proceed without reTURBT.	Procedure: Urine biomarker -Guided without reTURBT; Participants will proceed without reTURBT
No Intervention: Standard Care with reTURBT; Participants in this arm will receive standard care, which undergo reTURBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year RFS rate	the proportion of participants experiencing a recurrence during follow-up within 2 years	from initial TURBT to the first confirmed recurrence within 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFS	the duration from the completion of initial TURBT until the first recurrence of cancer is detected or until the end of the follow-up period, whichever comes first.	from initial TURBT to the first confirmed recurrence within 2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: reTURBT; NMIBC; urine biomarker; RFS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: 2023-SR-486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: by 2029 for 5 years
• IPD Sharing Access Criteria: will be shared under request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No